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news.Inovio Biomedical (Inovio) has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for its SynCon preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.
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Inovio is co-developing VGX-3400 with Korea-based VGX International. The 30-patient three-dose Phase I study will be conducted in multiple clinical research sites in Korea. A parallel study in the US is also planned for this year.
Inovio said that in pre-clinical studies, vaccination with VGX-3400 has generated broadly protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals in five separate animal models – mice, ferrets, rabbits, pigs, and rhesus monkeys.
Additionally, vaccination with VGX-3400 also protected animals from an unmatched, lethal H5N1 virus challenge in mouse, ferret, and monkey models.
Joseph Kim, president and CEO of Inovio, said: “Initiation of our H5N1 vaccine clinical trial marks an important milestone for our universal flu program. Inovio has been one of the first organisations to demonstrate a vaccine capable of providing protection against a broad set of unmatched influenza sub-types and strains, both seasonal and pandemic, in multiple animal models.
“If we achieve similar results in human studies, this universal vaccine concept has the potential to shift the current reactive paradigm of influenza vaccine design, manufacturing, and delivery. Such a shift would provide tremendous health and economic benefits worldwide.”